As the sun sets on 2006, I hope all my faithful readers and fellow bloggers have a wonderful New Year. 
Borrowing a page from Rolex watches and hybrid cars, a new pacemaker is under development that uses the patient's own movement to power its output.
UnitedHealth forecast 2007 net income in a range of $4.7 billion to $4.75 billion on revenue of about $79.5 billion. The company also backed its 2006 profit target, pegged in a range of $4.14 billion to $4.16 billion. These forecasts, UnitedHealth said, are based on expectations for "gains from increasing market share and strong operating margins" across its business units. In addition, the company targeted operating cash flow at about $6 billion to $6.2 billion next year.We know that doctors really appreciate your "margins" of health care coverage each time their patients open their "Explanation of Benefits" letters and have to pay progressively larger portions of their health care bill on top of their premiums to feed our beast. Thank you.
“For seizing the reins of the global media, for founding and framing the new digital democracy, for working for nothing and beating the pros at their own game, Time's Person of the Year for 2006 is you,'' staff writer Lev Grossman wrote in the cover story.Perhaps the blogging community is receiving this award from Time Magazine with measured tone because of something we bloggers already know. Just as the Internet has equalized the playing field in the media, we might consider a different hero next year.
… Michael Rapp, director of CMS's quality measurement and health assessment group, said the researchers most likely would have found bigger differences between hospitals if they'd examined all 22 quality measures used on Hospital Compare. Finding only slight differences when using a few measures is not surprising, Rapp said.Whoa there, Mr. Rapp. If I have a heart condition and want to find out about the World’s Best Hospital caring for heart disease, why do I need 21 or more other measures? But I know how you will clarify it for me:
Still, Rapp said he agrees that more quality measures are needed to evaluate hospitals. "CMS is actively working to expand quality measures used on Hospital Compare," Rapp said.Please, Mr. Rapp, give me more data do I can be even more confused. Give our patients more measure to make this “clear.” If the public can’t figure out Medicare Part D, how the heck are they going to decipher the 22 measures you already have, or 100, 200, or even 1000 measures? Is this how we're going to give “power to the people?”
The old guidelines called for repeated shocks along with a pulse check before administering CPR. The new way endorses a single shock followed by two minutes of CPR, the Heart Association said.In the EP lab where we witness cardiac arrest and all of its excitement first-hand, there is NO QUESTION that early defibrillation works. I have had times where one shock is not enough to resuscitate a patient in our lab setting. If I stopped to first perform CPR before shocking one of my patients during witnessed cardiac arrest, I am sure we would have a higher complication rate in our laboratory. Many of our patients have ischemic coronary disease, and when the heart fibrillates, no effective blood flow is pumped from the heart, cuasing it to be more susceptible to ventricular fibrillation, not less.
... it was six months and over 400 posts ago that we last hosted Grand Rounds. It's surprising how much has changed in that time, but also how much has stayed the same. We had a number of submissions from bloggers we featured last time around, along with a number of new faces. It seemed too that the quality of blogging has only continued to rise. Maybe it's simply a factor of writers becoming more comfortable with the medium. Or maybe it's a function of medical bloggers pushing each other to excel. Whatever it is, one thing is for sure: we the readers are the ones who truly benefit.Enjoy!
The new BVS stent is made of a polymer that dissolves into lactic acid over two to three years. Lactic acid is a naturally occurring substance in the body, produced after exercise. It breaks down into carbon dioxide and water, and is absorbed by the body.Unlike earlier bioabsorbable coatings over a bare metal stent, like the earlier Biomatrix stent, no bare metal exists in this stent. Of note, the stent also contains everolimus, and elutes this drug over an estimated 120 days. These patients are part of the ABSORB clinical trial enrolling up to 60 patients in Belgium, Australia, Denmark, France, the Netherlands, New Zealand, and Poland. While the initial results seem promising, there are a few caveats worth mentioning:
Congress agreed to erase a scheduled reduction in payments to physicians, but it made a 1.5% bonus payment available only to physicians who report to Medicare how they perform on certain specified barometers of health-care quality. Initially, the payments will be based on whether the physician reports the data, but the system lays the groundwork for higher payments to better-performing physicians.The implication of this bribery for reporting is significant, since it establishes a measly 1.5% premium on "Pay for Performance" - hardly a robust incentive. For instance, for a 20-minute outpatient follow-up visit that averages a $54 dollar Medicare reimbursement, Medicare is willing to pay an additional $0.81 for us to submit data about the drugs we give the patient. Since the payment isn't enough to offset the cost in man-hours to supply the data, will the data be complete or accurate?
Among the information Medicare officials will collect: whether doctors provide aspirin and beta blockers to patients having heart attacks, and whether elderly patients are screened for their risk of falls. These practices are considered indicators of good patient care.
Hospitals, too, will have greater responsibility for reporting quality-of-care data. While most hospitals already have been doing quality reporting on inpatient care, the new legislation requires them to do so for outpatient services to receive the full payment scheduled under law for those services. Congress added an additional wrinkle to the program in the latest legislation, requiring the Department of Health and Human Services to consider ways that the hospital data could be made available to the public.
"Fat may well be the next tobacco, and trans fat is likely to be one of the most promising targets, because it's so dangerous and totally unnecessary, and because there are so many legal theories under which it can attacked," says law professor John Banzhaf who helped lead the movement to sue cigarette manufacturers, and started the anti-obesity litigation movement.For lawyers it seems, it's not about health, it's about the money: over $24.5 million and counting ... look for more of them to join the feeding frenzy.
The FDA's drug-eluting stent safety panel recommended today that the labels of Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting) stents be changed to include a warning that off-label use of the devices may carry an increased risk of stent thrombosis, myocardial infarction, and death. The panel also called for the label to carry a recommendation for 12-months of dual antiplatelet therapy with aspirin and Plavix (clopidogrel) when drug-eluting stents are used off-label.This is a reasonable recommendation based on the paucity of data that exists to date. Look for new package inserts and for cardiologists contining their current treatments. Once formal recommendations are issued, some big trials like the SYNTAX trial, which compares stent therapy to cardiac bypass surgery for three-vessel and left main coronary disease, might need to change their consent forms and duration of clopidogrel (Plavix) therapy in the stent-treated arm.
The TAXUS Express 2 Paclitaxel-Etuting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions < 28mm in length in native coronary arteries > 2.5 to < 3.75 mm in diameter.And for Cordis' Cypher stent (pdf file):
The CYPHER® Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length < 30 mm in native coronary arteries with a reference vessel diameter of > 2.5 to < 3.5 mm.Your doctor can help you sort this out and most patients will be just fine, but some may need slightly longer anti-platelet therapy with aspirin and clopidogrel (Plavix).
BlueCompare is a program developed by Blue Cross and Blue Shield of Texas to enable more informed health care decisions by consumers.Oh, but don't worry:
This information is provided to assist you in selecting a health care provider. It is not intended to be a recommendation. (emphasis mine - wait, are you "assisting" or "recommending?") Your selection is a personal choice, and you should not base your decision solely on Affordability or Evidence Based Medicine (EBM) Indicators.Not a recommendation? Oh, pleeeeze! What else do you call it? A suggestion?
A memorandum sent out last month on city stationery asks department heads and senior staffers to give a "$35 voluntary donation (no checks please)" toward a gift for Mayor Richard Daley and his wife, Maggie.Seems that’s how things get done here in Chicago.
When the Tribune asked what the present would be, mayoral spokeswoman Jodi Kawada revealed Wednesday that a $2300 charitable donation will be made in the Daley’s names. The money will go to After School Matters, a program overseen by Maggie Daley that offers activities for city teenagers.Seems to me the names of all of the contributors should be mentioned, not the Daleys.
"Are we going to start to outlaw what everyone should eat in the city of Chicago? The City Council will be sitting in your kitchen to determine what you should eat on Sunday after church." - Mayor Richard Daley, ChicagoThe recently announced and much anticipated ban of trans fats in New York restaurants reminds me of the fois gras ban here in Chicago earlier this year. No one was there to enforce it and it looked like special interests (animal rights activists) got to tie up Chicago legislature with something that meant little to the general population, while ignoring other more pressing public health and safety issues. It was repealed a little over a month after it was signed into law. Will this new trans fat ban spread across the country or will the ban eventually be repealed? Right now, it's tough to know.
Citing patient safety, Pfizer said in a statement that it is terminating all clinical tests of torcetrapib and its plans to bring the drug to market. The company said it is asking doctors participating in studies of torcetrapib to tell patients to stop taking the drug immediately.The reason was too many deaths in the torcetrapib plus Lipitor (atorvastatin calcium) arm of the trial, compared to Liptor alone.
The company said that 82 patients taking a combination of torcetrapib and Lipitor died, compared with only 51 deaths among those taking Lipitor alone. Pfizer said the study cast no doubt on the safety and effectiveness of Lipitor.With such a large clinical trial, the excess deaths in the combination treatment arm of this trial could not go unnoticed.
In an unusual move, a federal judge has temporarily barred ousted UnitedHealth Group Inc. Chief Executive William McGuire from exercising stock options or receiving any retirement pay or other exit benefits while an external, board-appointed committee establishes whether the health insurer has claims against him.No so fast, Dr. McGuire. Let's see what the external committee decides. It is also interesting to note:
The order, which backs a joint motion by attorneys for several shareholder lawsuits and Dr. McGuire himself, puts on hold any agreement between UnitedHealth and its longtime chief executive over the terms of his departure until those legal questions have been answered. Dr. McGuire agreed to resign in October after an internal report concluded millions of stock options were likely backdated on his watch. He left the company yesterday with negotiations over his retirement package still unresolved.
The injunction is unusual in the annals of executive pay. U.S. District Judge James Rosenbaum of Minnesota handed it down late Wednesday partly at the request of attorneys representing a group of shareholder plaintiffs who have filed lawsuits against UnitedHealth. The complaints argue that the option backdating lined the pockets of Dr. McGuire and other top executives at the expense of the company. "If he were able to reap what we see as ill-begotten gains, we'd be asserting a claim without a remedy," said Karl Cambronne, lead attorney for the group.
Dr. McGuire also supported the plaintiffs' push for an injunction, and his attorneys even drafted the proposed court order, according to one person familiar with the situation said. The departing CEO believes the special litigation committee will vindicate him once "all the evidence is in," this individual said.Let's see, according to one set of outside reviewers, some would put the odds of Dr. McGuire having timed all those option dates just right was about 200 million to 1? And we're not even talking about those other set of double-issued options, are we?
The agency ... concluded an agreement with BG Medicine, a biotechnology research company, to collaborate on discovering signs of liver toxicity in the initial stages of drug development.BG Medicine's press release was a bit more detailed:
25 Oct 2005: BG Medicine, a Massachusetts-based biotechnology research company, today announced the submission of a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's National Center for Toxicological Research (NCTR), to jointly conduct a liver toxicity study designed to overcome one of the primary obstacles to the efficient development of safe and effective drugs. The study, Liver Toxicology Biomarker Study (LTBS), aims to discover biomarkers of human hepatotoxicity in the standard test used by pharmaceutical manufacturers in the initial stages of drug development.Now I'm not sure what I think about this. The FDA is supposed to assure the safety of pharmaceuticals to the public. While the bureaucratic quagmire called the FDA certainly needs to streamline their approval of drugs, are they able to maintain their objectivity regarding drug evaluations when they've become "best buddies" with the pharmaceutical industry by using Big Pharma's funds and facilities like this?
Liver toxicity is the most common biological reason for drug failure in the development of new pharmaceuticals, affecting one in six drugs in development. The toxicity tests currently in use by drug companies have been unchanged for at least 40 years and often fail to identify human liver toxicity issues. Consequently, liver toxicity is often detected for the first time when drugs are in phase 2 of clinical testing after tens of millions of dollars or more have been spent on a drug.
On March 16, 2004 the FDA released a report, "Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products," describing the "urgent need to modernize the medical product development process -- the Critical Path -- to make product development more predictable and less costly." The proposed project addresses the liver toxicity issue highlighted in the Critical Path document as one of the obvious and priority areas for innovation.
The CRADA process is a standard procedure for studies the FDA undertakes in collaboration with private companies. The liver toxicity study has been designed by BG Medicine and the FDA with input from a number of pharmaceutical companies. The study will be funded by and conducted in collaboration with pharmaceutical manufacturers. (Emphasis mine)
The research project leverages NCTR's and BGM's systems biology platforms for functional genomics, proteomics, metabolomics and computational analysis.
The LTBS will be conducted at the FDA's NCTR laboratory in Jefferson, Arkansas and at BG Medicine in Waltham, Massachusetts. The study is open to participation by all pharmaceutical manufacturers. Participating companies will receive a paid-up perpetual license to any biomarkers discovered and access to all project data.
The centerpiece of the research will be a study of 4,000 to 6,000 Humana patients with at least two known risk factors for heart attacks. As the outcome for the patients becomes clear over the next few years, researchers hope the profiles that emerge from the study will, in hindsight, show patterns pointing directly to the high-risk patients who actually suffered heart attacks. That in turn could help the companies create new therapeutic products.I'm not sure of their motivation here, but I wonder how much revenue and "best practices data" they receive for supplying the patients for this trial. Hmmm. It seems only Humana patients will be participating in this "research." Why?
At my age 600 years ago, even if I were Eric I of England, I’d likely be reposing in a splendid crypt. As it is, I’m perfectly healthy and taking the kids to see their grandmother in Pittsburgh, entertaining them in the mini-van with a tiny electronic slab that holds 1,500 songs, eight podcasts and two unabridged books on tape.Yes, he’s solidly, and remarkably, in “mid-life” with plenty of years still ahead.